FDA.reportPublic FDA data

510(k) K862665

Device
NOVACYTE-U
Applicant
XSIRIUS MEDICAL, INC.
510(k) number
K862665
Product code
KDT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-04
Date received
1986-07-14
Regulation
864.3250
Classification name
Container, Specimen Mailer And Storage, Sterile
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ERIC LIETZ
Address
Peninsula Pt.e Suite 260 27520 Hawthorne Blvd. Rolling Hills Estates CA US 90274 90274

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873593BIOSURE SPECIMEN COLLECTION CONTAINERBiosure, Inc.1987-11-25
K834579BIOSPAL 2400SHospal Medical Corp.1984-02-04
K834412PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.1984-01-13
K833660PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.1983-11-28
K823773PROVIAL II #006-010-0201Dynatech Corp.1983-01-21
K822870STOOL-COLLECTION/PRESERVATION KITAmerican Scientific Products1982-11-01
K821621PREGNOPOSTM.M. Wolfred, Ph.D.1982-07-21
K820246PREFILLED SPECIMEN CONTAINERSage Products, Inc.1982-02-18
K811793FIX-RIGHT 90ML & 180 ML PREFILLED CONTRichard-Allan Medical Ind., Inc.1981-07-31
K800946URINARY CATHETER SAMPLING KITSage Products, Inc.1980-06-20
K770071PINLOCK CONTAINERPerkins Mfg. Co.1977-02-24

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases